NCT03559348已完成2 期
Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
National Health Research Institutes, Taiwan2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年4月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Multiple centers, uncontrolled, open-label, non-randomized single-arm study
详细描述
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)
Secondary objectives:
Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
- •Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
- •Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
- •Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- •Baseline ECOG performance status is
- •Patients have life expectancy of at least 12 weeks.
- •Patients have age 70 years.
- •Patients have adequate organ function.
- •Patients with biliary obstruction which is adequate drained before enrollment are eligible.
- •Patients agree to have an indwelling venous catheter implanted.
- •Women or men of reproductive potential should agree to use an effective contraceptive method.
- •All patients must be informed of the investigational nature of this study and must sign written informed consents.
排除标准
- •Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- •Patients with metastatic lesion in central nervous system.
- •Patients with active infection.
- •Patients with active cardiopulmonary disease or history of ischemic heart disease.
- •Patients who have peripheral neuropathy > grade I of any etiology.
- •Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
- •Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 5.0 months
The progression-free survival time for elderly patients with advanced pancreatic cancer
次要结局
- Overall tumor response rate(up to 18 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study of S-1 Plus LV for Advanced Gastric CancerGastric CancerNCT02090153Sun Yat-sen University39
已完成
2 期
Study of S-1 Plus LV for Untreated Metastatic Colorectal CancerColorectal CancerNCT00891332Taiho Pharmaceutical Co., Ltd.73
未知
2 期
A Randomized Phase II Study of S-1 plus Leucovorin versus S-1 alone in Patients with Gemcitabine-Refractory Advanced Pancreatic Cancer.Pancreatic cancerJPRN-jRCT2080221515Taiho Pharmaceutical Co., Ltd.140
已完成
2 期
Phase II study of S-1, leucovorin plus bevacizumab in refractory colorectal cancerColorectal cancerJPRN-UMIN000009083Aichi Cancer Center Hospital, Department of Clinical Oncology30
Unknown
2 期
S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal CancerColorectal CancerNCT01193452Fudan University100